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  • Regulatory NewsRegulatory News

    After New Drugs Delayed by DEA, Legislators Seek Overhaul of Drug Scheduling Process

    For most pharmaceutical products in the US, obtaining approval from the US Food and Drug Administration (FDA) to market a product means a company can begin selling its product as soon as it wants. But for a subset of products subject to the Controlled Substances Act (CSA ) , the Drug Enforcement Administration (DEA)—not FDA—is the ultimate arbiter of when market access occurs and the extent to which it occurs. Now new legislation wants to make the process by which DEA ...
  • Regulatory NewsRegulatory News

    DEA Establishes Production Limits for Painkillers, With Some Drugs Set for Big Increases

    US drug regulators have set new production quotas for dozens of controlled substances regulated under the Controlled Substances Act (CSA) , establishing the quantities of the drugs which may be produced in 2015. Quota Adjustments In a 5 September 2014 Federal Register notice , the US Drug Enforcement Administration (DEA), which is charged with setting the quotas, released a list of dozens of schedule I and II controlled substances which will be subject to produc...
  • Regulatory NewsRegulatory News

    Merck's Insomnia Drug Belsomra Clears Final DEA Hurdle

    The US Drug Enforcement Administration (DEA) has given a final and long-awaited approval to Merck to market its new insomnia drug Belsomra (suvorexant) as a Schedule IV drug. Background Belsomra is an orexin receptor antagonist intended to treat insomnia in patients. While its sponsor, Merck, has already obtained FDA approval to market the drug, it has been awaiting scheduling by DEA as a controlled substance under the Controlled Substances Act (CSA) . In February 2...
  • Regulatory NewsRegulatory News

    DEA, Following FDA Recommendation, to Toughen Regulation on Popular Class of Painkillers

    In a long-anticipated move, the Drug Enforcement Administration (DEA) has announced it will now regulate all hydrocodone combination products as Schedule II drugs under federal law. The move follows an October 2013 recommendation by the US Food and Drug Administration (FDA), which also recommended that the drugs be regulated as Schedule II products under the Controlled Substances Act (CSA), a 1970 law which places controls on substances known to be dangerous, prone to ...
  • Bill Aims to Speed up Regulatory Process for Abuse-Prone Drugs

    A new piece of legislation introduced today by a bipartisan congressional duo calls for the improvement of a current regulatory stumbling block that some companies have likened to a "black hole." Background While the US Food and Drug Administration (FDA) determines whether a drug is safe and effective in the US, the determination of whether its component parts are addictive or prone to abuse falls under the authority of the US Drug Enforcement Administration (DEA) and t...
  • Attempt to Strengthen Restrictions on Hydrocodone Products Clears Second-to-Last Hurdle

    The Drug Enforcement Administration (DEA) has released a proposed rule that adopts a recommendation by the US Food and Drug Administration (FDA) to reschedule combination hydrocodone products as Schedule II substances under the Controlled Substances Act (CSA) . Background In the US, access to opioid-based painkiller medications has long been the topic of a contentious debate. On one side have been patient advocates and some doctors, who say opioids should be easily ava...
  • Will Merck's Suvorexant Avoid DEA's Regulatory 'Black Hole' That Snared Arena's Belviq?

    Merck's insomnia drug Suvorexant may not be approved yet by the US Food and Drug Administration (FDA), but if it ever is, its path to market will probably be even shorter thanks to a decision made by the US Drug Enforcement Administration (DEA) this week. Background Suvorexant is an investigational orexin receptor antagonist intended to treat insomnia in patients. While its sponsor, Merck, has already completed several Phase III trials in support of the drug's mark...
  • Congress Presses DEA to Open up on Regulatory 'Black Hole'

    Once, professionals engaged in pharmaceutical regulatory affairs had only one agency to worry about: the US Food and Drug Administration (FDA), which has principal authority over whether a drug is safe and effective for use. But in recent years the US Drug Enforcement Agency (DEA) has begun to flex its influence on the approval of some products with the potential for abuse, and now members of Congress are taking notice, demanding answers about the lack of transparency in ...
  • After Nearly a Year in Regulatory 'Black Hole,' Arena Gets DEA's Approval for Weight Loss Pill Belviq

    After a lengthy wait, the Drug Enforcement Administration (DEA) has announced the classification of lorcaserin, better known as Arena Pharmaceuticals' weight loss drug Belviq, as a Schedule IV controlled substance under the Controlled Substances Act (CSA) . The announcement comes after months of waiting by Arena. When Belviq was approved in June 2012, it was heralded as the start of a sea change in the regulatory paradigm for obesity drugs. Prior to its approval, no obe...
  • Civil Rights Group Argues for Protection of Prescription Databases

    The American Civil Liberties Union (ACLU), a constitutional and legal advocacy group, is filing a lawsuit against the Drug Enforcement Administration (DEA) in light of what it calls a constitutionally dubious encroachment on the prescription drug use records of US citizens. In a statement posted to its website on 25 January 2012, the organization said it had been made aware of DEA's efforts to "access private prescription records of patients in Oregon without a warrant, ...
  • DEA's Regulatory Agenda Affects Pharma Supply Chain, Distribution and Disposal Regulations

    The US Food and Drug's Administration's (FDA) Unified Agenda may have been released late last year, but it's not the only US regulatory agency with the potential to affect the medical device and pharmaceutical industries. Several regulations proposed by the Drug Enforcement Administration (DEA), a division of the US Department of Justice, hold the potential to affect members of industry, and in particular the pharmaceutical industry. One such proposed rule, Disposal of...
  • DEA Classifies Bath Salt Chemical as Schedule I Drug After Oversight

    • 18 October 2012
    The Drug Enforcement Administration (DEA) has placed methylone, a powerful stimulant and psychoactive drug most notorious for its presence in bath salts, into its Schedule I of highly restricted drugs with no accepted medical use within the US. The drug is chemically similar to other drugs like Ecstasy (MDMA), which has been a Schedule I drug under the Controlled Substances Act (CSA) since 1985. DEA's actions would act to put into place a more permanent solution, o...